Chapter 156: Ministry of Food and Drug Safety (11)

There was tension in the conference room. Heo Song-Hyuks hand trembled as he flipped each page of the preclinical data.

We lost.

Oh Hyun-Dong instinctively knew that they had completely lost. This was almighty; Young-Joon was here with evidence that could not be beaten. A clinical trial was an experiment done on humans. The preclinical experimentation process was obviously done on animals, as it would become a clinical trial the moment they used it on an actual person. And in preclinical stages, the bonobo was the final boss. Bonobos were on the brink of being human, and they were the closest to humans of all the creatures on the planet.

What could the evaluators do when Young-Joon had proved that the drug worked in bonobos? He had given them this, and they wanted more data? How? The only thing left would be humans, and that wouldnt be preclinical data. Better clinical data could not logically exist.

Its over.

The evaluators were underwater as soon as the meeting started.

N-No way Is this real? Heo Song-Hyuks voice was filled with panic. Doctor Ryu, the exportation of bonobos is illegal. Thats why there haven't been any preclinical experiments done with bonobos in the past few decades.

But I made a deal with the Congolese government and acquired them. Since I needed an animal that had the human mind, and the bonobo was the best example.

...

There is no better preclinical data than this. You have to give me approval for a clinical trial.

Sigh

A few of the evaluators wrapped their hands around their heads.

I know you are afraid, and I know that this is quite an ambitious treatment, Young-Joon said. Pharmaceutical companies or patients could take the risk after considering the rewards, but not the MFDS.

...

If it fails, the MFDS will be criticized for the oversight and the lack of validation. But even if it succeeds, no one gives you credit.

When news of a new drugs success in clinical trials came out, patients celebrated and the pharmaceutical companys stock prices soared. The media praised the developers of the drug and painted a rosy picture of the future that was full of hope.

However, the Ministry of Food and Drug Safety was not part of the celebration. The performance of the governmental department that oversaw clinical trials was usually not even recognized by the government either. No political party that had come into power had advertised that they had approved of some new drug as their achievement. The reason that no one has done that was because no one thought that the MFDS contributed anything to developing that drug.

The only perception that existed was blame when the drug failed. The MFDSs contribution in verifying and overseeing clinical trials so that it goes well was only perceived as an obstacle to drug development.

I know that it is a lot of pressure for the MFDS to approve a clinical trial since even if a drug is fully tested and approved, side effects can be reported later. The MFDS is one of the organizations that only gets blamed without any praise, Young-Joon said.

...

But this drug has to be approved. There are five hundred thousand people with schizophrenia in Korea alone. Theres seventy million people in the world. Do you really want me to go overseas with this data?

We can grant approval for most things as you want, Heo Song-Hyuk said. But not this, Doctor Ryu. We will tell you the reason if you want.

What is it?

There hasnt been any long-term observation of side effects and verification.

We confirmed that the administered mitochondria were all killed and excreted. There is no way that side effects that dont occur at the time of administration would occur after a long period of time. Thats an excuse.

... I am firm on that decision. It cannot be approved unless it has been verified through long-term observation. Come back in a few years with more data or conduct the trial overseas, Heo Song-Hyuk said.

Sir

Some of the evaluators were inclined. Some of them wanted to just grant approval since Young-Joon had done so much. But Heo Song-Hyuk was adamant.

Heo Song-Hyuk was the old guard of the Ministry of Food and Drug Safety who was about to retire. He survived for a long time in a ministry that, as Young-Joon said, was only criticized. Heo Song-Hyuk believed the secret to his survival was not taking risks. To be honest, he wasnt sure about his decision now, as Young-Joon had accomplished so much.

However, clinical trial approval was about the drug, not the person.

The data is irrefutable, but this is too much. Youre putting in bacteria in the brain.

Heo Song-Hyuk comforted himself.

I am not doing something bad. Sending adventurous drugs to be tested in other countries is something that other administrations do.

Heo Song-Hyuk thought to himself.

I am not avoiding blame. I am trying to protect the nation. As an employee of the MFDS, I have to be extremely conservative.

Rustle.

Young-Joon gathered up the document. He put them in his folder and put it in his bag.

I am very disappointed, Young-Joon said. I could do the clinical trial overseas. Like a few other multinational pharmaceutical companies, I could do it in underdeveloped countries or ones that are in civil war. I could take illiterate people and trick them into giving consent and do the clinical trial however I want. Is that what you want?

...

Isnt it the MFDSs job to protect the health of the nation from all kinds of dangerous drugs and products? Young-Joon asked. But I am doubtful of those intentions when you cant muster up the courage to connect this preclinical data to patients. Is that what you really want to protect, or is it your safe retirement?

...

Heo Song-Hyuk chewed on his lower lip. Young-Joon left the conference room. Then, he pulled out his phone and called Park Joo-Hyuk.

It didnt go well.

Got it.

* * *

Conducting the clinical trial overseas was the worse option for two reasons. First, it was more difficult to get his drug into a clinical trial overseas because it was developed by a domestic company, not by international research. Second, foreign drug regulatory authorities would become suspicious as to why Young-Joon wasnt conducting the clinical trial in his own country if he applied for a clinical trial overseas. Naturally, the drug regulatory authorities would analyze the data more meticulously and would be hesitant to grant approval.

However, Young-Joon had a second card up his sleeve; it was time to put Park Joo-Hyuks strategy into action.

The next morning

[A-Bio develops schizophrenia cure]

[Treatment verified in bonobos, which have similar minds to humans.]

[What are bonobos?]

[The significance of curing mental disorders.]

[How much is our society spending on schizophrenia?]

By the afternoon, a bunch of press releases poured out. There was even a paper published.

[Ryu Young-Joon publishes a paper on schizophrenia treatment on BioRxiv.]

If Young-Joon submitted his paper to

Science

, it would take time to be released. Instead of sending it to

Science

, he published it as a draft on BioRxiv, a site that distributed scientific papers for free. This paper would be published in

Science

later. Now, everyone in the world could see the experimental data on bonobos.

No way

Heo Song-Hyuk realized that he had made a mistake. He had misjudged the situation. Young-Joon was not someone who would go down without a fight. He had no intention to go overseas, and he wasnt willing to wait years; he was trying to end this once and for all.

Then, a much more shocking article was published.

[Choo Eun-Pil, the perpetrator of the Jungyoon University Station incident, volunteers for the clinical trial.]

What is this

Surprised, Heo Song-Hyuk opened the article.

The Jungyoon University Station incident: it was a tragic incident where a crazy person swung a knife at students walking to class in the morning. Five people died and two people were seriously injured. The deaths of these promising young men at a prestigious university shocked rippled through the country. That was when the association between schizophrenia and violent crime had peaked. Some suggested that people with schizophrenia should be directly detained and monitored by the government.

The defendant was not lucid when that incident occurred.

That was what Choo Eun-Pils defense argued at the trial. Choo Eun-Pil did not say anything because they didnt have the cognitive ability to even speak.

Choo Eun-Pil continued to receive medical treatment while incarcerated. Their condition improved slightly and they were still all over the place, but there were times where they would be lucid.

I thought those people were trying to kill me. I thought they poisoned my breakfast every morning. I dont even have breakfast, but I thought that I would die if I didnt harm them, Choo Eun-Pil said two years into treatment while incarcerated.

Then, they heard that Young-Joon had developed a schizophrenia treatment, and this was before the press release. They heard it because of Park Joo-Hyuk and Song Jong-Ho.

Park Joo-Hyuk slipped the news that the MFDS had refused to approve a clinical trial to the pharmaceutical society. Song Ji-Hyun quickly caught wind of the information and asked Young-Joon about confidentiality and got his permission to distribute it. The information was passed on from Park Joo-Hyuk to the pharmaceutical society, then Song Ji-Hyun, then Song Ji-Hyun, then finally to the schizophrenia community. It was the [People who have overcome schizophrenia]. It was a non-profit organization with tens of thousands of patients with schizophrenia, including Song Jong-Ho. They also had contact with Choo Eun-Pil. Choo Eun-Pil, who had gotten information of the new drug Young-Joon made and the clinical trial, believed this was their destiny.

This is what I have to do.

Choo Eun-Pil felt that this was a final act of reparation for all the schizophrenia patients they had inconvenienced. They decided to give courage to other patients by volunteering for the clinical trial.

* * *

Producer Na Sung-Jin was contacted by Young-Joon. Surprisingly, the scientist who only stopped doing research at night when he was sleeping, volunteered to give a lecture. It was because he wanted to clear up misconceptions about schizophrenia and explain the new treatment.

The mitochondria is an organelle that naturally exists in human cells. What we have done is take those mitochondria, make them into bacteria and multiply them, then deliver them into the brain with genes that can cure schizophrenia, Young-Joon said. I will be honest. The brain is originally the most important organ in the body that receives special protection from external infections. Its not a normal situation to have bacteria in a place like that.

Young-Joon looked straight into the camera.

Because of the risky means, I consulted with the Ministry of Food and Drug Safety while developing this treatment. As expected, they wanted to be very conservative and meticulous in verifying the preclinical data. They said that they wouldnt allow us to use it on people with mere experimental data on animals like rats or beagles. Because of that, we had to take the more difficult path.

Young-Joon opened the data from the published paper.

This is the result. Its a preclinical experiment that the creativity of A-Bio and the rigor of the MFDS created, Young-Joon said. This is preclinical data from a very unusual animal called bonobo, which is the most similar animal to humans. We used primates that were much more similar to humans rather than beagles.

Young-Joon talked about the interpretation and explanation of the results for about half an hour.

In this way, we demonstrated both safety and efficacy, and we expect to be able to conquer schizophrenia now.

When Young-Joon finished his talk, the MC asked him the question that everyone was curious about.

Are you planning a clinical trial?

Heo Song-Hyuk and the evaluators who were watching the broadcast on television had sweat in their palms.

Yes, Young-Joon said.

Wow, the MC explained. Doctor Ryu, many patients with schizophrenia, including Choo Eun-Pil, are volunteering to participate in the clinical trial. When do you think it will begin?

Like any country, we can begin as soon as we go through the legal process. We are ready, Young-Joon said. And half of the credit for producing this important data goes to the MFDS. Even when I asked for a clinical trial, they defended it, almost too rigidly, because they were worried about the health of the people. We were able to get data on bonobos because of them. If it wasnt for them, we could have tried to start clinical trials with much weaker data. I hope you give them all your praise.